IMvigor130 is an ongoing study in previously untreated patients
with metastatic urothelial carcinoma who are eligible for
platinum-containing chemotherapy. Both cisplatin-eligible and
cisplatin-ineligible patients are included in the study. The
independent Data Monitoring Committee (iDMC) for the study conducted
a review of early data and found that patients classified as having
PD-L1 expression of <5% when treated with TECENTRIQ monotherapy
had decreased survival vs those who received platinum-based
chemotherapy. The iDMC recommended closure of this TECENTRIQ
monotherapy arm to further accrual of patients with low PD-L1
expression. There were no other changes recommended for the study,
including any change in therapy for patients already randomized to
and receiving treatment in the TECENTRIQ monotherapy arm.

†A confirmatory Phase III IMvigor211 study that evaluated
TECENTRIQ® (atezolizumab) in people with locally advanced
or metastatic urothelial cancer (mUC) whose disease progressed
during or after treatment with a platinum-based chemotherapy
(previously treated) did not meet its primary endpoint of overall
survival (OS) compared with chemotherapy. TECENTRIQ maintains its
accelerated approval for both first-line cisplatin-ineligible and
previously platinum-treated mUC patients. The cisplatin-ineligible
patient population was not studied in IMvigor211. (Announced May 2017)

Important Safety Information and Indication

Indication

TECENTRIQ is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who:

Are not eligible for cisplatin-containing chemotherapy, and whose tumors express PD-L1 (PD-L1–stained tumor-infiltrating immune cells [IC] covering ≥5% of the tumor area), as determined by an FDA-approved test, or

Are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status, or

Have disease progression during or following any platinum-containing chemotherapy, or within 12 months of neoadjuvant or adjuvant chemotherapy

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Serious Adverse Reactions
Please refer to the full Prescribing Information for important dose management information specific to adverse reactions.

Monitor patients for signs and symptoms of pneumonitis. Evaluate patients with suspected pneumonitis with radiographic imaging. Administer corticosteroids followed by a taper. Withhold TECENTRIQ for Grade 2 and permanently discontinue for Grade 3 or 4 pneumonitis

Monitor patients for signs and symptoms of hepatitis, during and after discontinuation of TECENTRIQ, including clinical chemistry monitoring. Administer corticosteroids followed by a taper for immune-mediated hepatitis. Withhold TECENTRIQ for AST or ALT elevations more than 3 and up to 8 times the upper limit of normal or total bilirubin more than 1.5 and up to 3 times the upper limit of normal. Permanently discontinue TECENTRIQ for AST or ALT elevations more than 8 times the upper limit of normal or total bilirubin more than 3 times the upper limit of normal

Immune-Mediated Colitis

Immune-mediated colitis or diarrhea have occurred with TECENTRIQ treatment

Across clinical trials, diarrhea or colitis occurred in 20% of patients, including Grade 3 (1.4%) events

Monitor patients for signs and symptoms of diarrhea or colitis. Withhold TECENTRIQ for Grade 2 or 3 and permanently discontinue for Grade 4 diarrhea or colitis

TECENTRIQ can cause severe and fatal immune-mediated adverse reactions. These immune-mediated reactions may involve any organ system

Across clinical trials, cardiac, dermatologic, gastrointestinal, general, hematological, musculoskeletal, neurological, ophthalmological, renal, and vascular immune-mediated adverse reactions occurred at an incidence of <1% in patients who received TECENTRIQ or were reported for other products in this class of therapy

Monitor for signs and symptoms of infusion-related reactions. Interrupt or slow the rate of infusion in patients with Grade 1 or 2 infusion-related reactions. Permanently discontinue TECENTRIQ in patients with Grade 3 or 4 infusion-related reactions

Embryo-Fetal Toxicity

Based on its mechanism of action, TECENTRIQ can cause fetal harm when administered to a pregnant woman. Verify pregnancy status of females of reproductive potential prior to initiating TECENTRIQ. Advise females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with TECENTRIQ and for at least 5 months after the last dose

Nursing Mothers/Fertility

Because of the potential for serious adverse reactions in breastfed infants from TECENTRIQ, advise female patients not to breastfeed while taking TECENTRIQ and for at least 5 months after the last dose

Based on animal studies, TECENTRIQ may impair fertility in females of reproductive potential while receiving treatment

Most Common Adverse Reactions
The most common adverse reactions in cisplatin-ineligible UC (rate ≥20%) were fatigue (52%), decreased appetite (24%), diarrhea (24%), and nausea (22%).

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